Patent law in the field of biotechnology and genetic engineering: implementation report (2005)

This second report focuses on issues relating to the patenting of sequences of genes which have been isolated from the human body and the patentability of inventions concerning stem cells. It also reports on the implementation of the Directive on the legal protection of biotechnological inventions.

ACT

Report from the Commission of 14 July 2005 - Development and implications of patent law in the field of biotechnology and genetic engineering [COM(2005) 312 - Official Journal C 211 of 30.8.2005].

SUMMARY

The Commission drew up this report on the basis of the work carried out by the group of experts set up following the first report.

It presents an analysis of the two issues which had been raised in 2002:

the patenting of sequences of genes which have been isolated from the human body

The aim was to determine the scope of the protection conferred by patents to this type of product: classical protection covering possible future uses of the sequence or protection restricted only to the specific use disclosed in the patent application ("purpose-bound protection").

The Commission has not taken a position so far regarding the scope of Member States' protection. It will, nonetheless, monitor the matter closely to determine whether there are any economic consequences of possible divergences between Member States' legislation.

the patentability of human embryonic stem cells and cell lines obtained from them

A distinction should be drawn between totipotent stem cells, which are capable of developing into a human being, and pluripotent embryonic stem cells, which do not have this capability.

The former are clearly excluded from patenting on grounds of human dignity.

For the latter, the group of experts considered that the question of patenting was linked to the definition of what constitutes an embryo, and the scope of research allowed, which is determined by national legislation. Given the divergences which exist between Member States on this matter, the Commission considers that it is premature to give further definition or provide for further harmonisation in this area.

The Commission will monitor developments in this field and has launched a study looking at the ethical and legal aspects of stem cell patenting.

It draws attention to the initiation of legal proceedings in 2003 for failure to transmit transposition measures and the opening of new procedures in December 2004 against Latvia and Lithuania which had not completed the transposition of the Directive. Italy and Luxembourg had also still not applied the Directive in July 2005.

RELATED ACTS

Report from the Commission of 7 October 2002 - Development and implications of patent law in the field of biotechnology and genetic engineering COM(2002) 545 final [Not published in the Official Journal]

This document is the Commission's first annual report aimed at evaluating the implementation of Directive 98/44/EC on the legal protection of biotechnological inventions. It examines the development of patent law in the field of biotechnology and genetic engineering, and identifies and evaluates problems and sensitive issues which have recently arisen.

European Parliament and Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions [Official Journal L 213 of 30.07.1998]

The purpose of this Directive is to guarantee clear and effective legal protection in the field of biotechnology. It also specifically bans human cloning and any modifications to germ line genetic identity. The ethical aspects are handled by an independent committee which has been given the task of advising the European Commission on these matters.